MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BIOMET TIBIAL LOCKING BAR; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	07/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Foreign report source: (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported patient was revised approximately two weeks post implantation due to implant loosening.Additional information on the reported event is unavailable.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: d10; h2; h3; h6 complaint sample was evaluated and the reported event was confirmed.Visual inspection of the returned locking bar exhibits signs of being implanted (nicks, gouges).The sem analysis report states that even though the examined locking bar contact mark and deformation observations are consistent with the bars not being fully engaged with the tibial tray lugs, it cannot be determined with certainty whether the reported locking bar dissociations occurred due to improper insertions.A more definitive conclusion would require analysis of not just the locking bars, but also of the mating tibial trays as well as the implanted bearings.X-ray review states that no loosening was identified.Slight medial extension of the medial portion of the tibial tray which extends slightly medial to the cortex of the proximal tibia.This may be intentional and is not further evaluated radiographically.The device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Analysis of the locking bar determined that the locking bar contact mark & deformation observations are consistent with the bar not being fully engaged with the tibial tray.However, it cannot be confirmed with certainty whether the reported locking bar dissociation occurred due to improper insertion and a definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: BIOMET TIBIAL LOCKING BAR
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10265067
• Report Number: 0001825034-2020-02733
• Device Sequence Number: 14028810
• Product Code: JWH
• UDI-Device Identifier: 00880304009738
• UDI-Public: (01)00880304009738
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K171054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 141205
• Device Lot Number: 508720
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/02/2020
• Supplement Date Received by Manufacturer: 10/30/2020
• Initial Report FDA Received Date: 07/13/2020
• Supplement Report FDA Received Date: 11/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention